Hereditary Angioedema
Conditions
Brief summary
Number and proportion of subjects with a treatment-related TEAE, Number and proportion of subjects who experience a serious adverse event (SAE), Number and proportion of subjects who experience a treatment-related Grade 3 or 4 TEAE, Number and proportion of subjects who experience a treatment-related Grade 3 or 4 treatment-emergent chemistry abnormality, Number and proportion of subjects who discontinue due to a TEAE
Detailed description
Another mechanism is available to provide drug to the subject(eg, market access), or until the sponsor discontinues all global commercialization and development of berotralstat for the prevention of angioedema attacks, whichever comes first
Interventions
DRUGBerotralstat
DRUGBEROTRALSTAT
Sponsors
Biocryst Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and proportion of subjects with a treatment-related TEAE, Number and proportion of subjects who experience a serious adverse event (SAE), Number and proportion of subjects who experience a treatment-related Grade 3 or 4 TEAE, Number and proportion of subjects who experience a treatment-related Grade 3 or 4 treatment-emergent chemistry abnormality, Number and proportion of subjects who discontinue due to a TEAE | — |
Secondary
| Measure | Time frame |
|---|---|
| Another mechanism is available to provide drug to the subject(eg, market access), or until the sponsor discontinues all global commercialization and development of berotralstat for the prevention of angioedema attacks, whichever comes first | — |
Countries
Czechia, France, Germany, Italy, Poland, Slovakia, Spain
Outcome results
None listed